Process Engineer I

A brief overview

A process engineer is responsible for supporting and maintaining critical and supporting equipment and instruments to ensure the manufacturing process is continuously in operation with minimal downtime. Concurrently, through process mapping, the process engineer is responsible to develop process improvement projects to create efficiency in the process. The process engineer will also be responsible for identifying and researching background for equipment purchases and making recommendation to management.

What you will do

• Support the Director on capital projects for facility remodeling and expansion
• Perform activities associated with the design and qualification of the new and existing equipment used in a manufacturing plant
• Lead the process development, optimization and scale-up of lyophilization processes to cGMP and FDA-compliant
• Oversee implementation, commissioning, and qualification of clean room spaces and process equipment
• Ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced
• Maximize the success rate for production operations by instituting programs to minimize human error, mechanical failure, contaminations, and procedural error
• Support strategic plans for process and plant improvements in order to increase efficiency and manage costs.
• Maintain a safety first approach to process development and manufacturing
• Communicate operational status regularly to senior management and to corporate management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
• Maintain a high level of compliance and efficiency to drive the organization to world-class manufacturing standards
• Write design qualifications for qualifying batch processing tanks, reactors, filter dryers, HPLCs, filtration system, lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water
• Create new process and equipment drawings to existing processes based on specifications and standards
• Update drawings and P& reflect changes to existing processes
• Maintains drawing files (CAD, P&, PDF, and hard copies)
• Responsible for trouble shooting and providing corrective action directives
• Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities
• Create, execute validation protocols and write validation summary reports
• Draft of new procedures, SOP’s and protocols as well as training of staff for these expectations
• Perform process development studies for new and existing projects
• Write summary reports to support the process development data
• Write standard operations procedures, standard test procedures, master batch records and other related GMP documents

Qualifications

• Bachelor s Degree BS degree in Mechanical, Electrical, Chemical, Manufacturing Engineering or a Science related field required or
• Master s in Mechanical, Electrical, Chemical, Manufacturing Engineer or a Science field preferred
• 1 - 3 years experience within a pharmaceutical manufacturing operations required
• Specific knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles
• Understanding of engineering fundamentals
• Technical knowledge of processes/equipment/utilities (e.g. batches processing, tank, filtration, lyophilization, purified water system, HVAC, etc.)
• Equipment Qualification and Validation IQ/OQ/PQ, SOPs
• Excellent written and oral communication skills
• Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
• Ability to work independently and manage one’s time
• Basic computer knowledge, including Microsoft Word and Excel (used daily)
• Communicate effectively and ability to function well in a team environment
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Detail oriented with the ability to troubleshoot and resolve equipment problems.
• Strong analytical math and problem solving skills
• Proficient in reading schematics and diagrams as well as other written materials
• High level of safety awareness

Base…